Application 012616

Type: NDA
Sponsor: GD SEARLE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
004	ALDACTAZIDE	HYDROCHLOROTHIAZIDE; SPIRONOLACTONE	TABLET;ORAL	25MG;25MG	Yes	No
005	ALDACTAZIDE	HYDROCHLOROTHIAZIDE; SPIRONOLACTONE	TABLET;ORAL	50MG;50MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N012616-004	ALDACTAZIDE	HYDROCHLOROTHIAZIDE; SPIRONOLACTONE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30
N012616-005	ALDACTAZIDE	HYDROCHLOROTHIAZIDE; SPIRONOLACTONE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N012616-004	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD	1982-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD, RS	1982-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD, RS	1982-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD, RS	1982-12-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD, RS	1982-12-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012616-004	ALDACTAZIDE	25MG;25MG	TABLET / ORAL	AB	RLD	1982-12-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N012616-005	ALDACTAZIDE	50MG;50MG	TABLET / ORAL		RLD, RS	1982-12-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N012616-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N012616-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012616-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012616-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012616-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012616-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012616-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012616-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012616-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012616-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012616-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012616-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012616-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012616-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012616-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012616-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012616-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012616-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012616-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012616-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012616-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012616-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012616-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012616-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012616-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012616-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012616-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012616-004	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012616-004	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N012616-004	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N012616-004	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012616-004	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012616-004	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012616-004	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012616-004	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012616-004	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012616-004	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012616-004	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N012616-004	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N012616-004	AB	1	`e64feba35796…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Spironolactone and Hydrochlorothiazide	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	Prasco Laboratories	9d350fa2-d568-4970-a7a5-d128ff5d0a2f	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 012616 application number: NDA012616 ndc (product): 66993-188

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0025-1011	ALDACTAZIDE	spironolactone and hydrochlorothiazide	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1011	ALDACTAZIDE	spironolactone and hydrochlorothiazide	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1011	ALDACTAZIDE	spironolactone and hydrochlorothiazide	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1011	ALDACTAZIDE	spironolactone and hydrochlorothiazide	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1011	ALDACTAZIDE	spironolactone and hydrochlorothiazide	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1011	ALDACTAZIDE	spironolactone and hydrochlorothiazide	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1021	ALDACTAZIDE	spironolactone and hydrochlorothiazide	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1021	ALDACTAZIDE	spironolactone and hydrochlorothiazide	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1021	ALDACTAZIDE	spironolactone and hydrochlorothiazide	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1021	ALDACTAZIDE	spironolactone and hydrochlorothiazide	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1021	ALDACTAZIDE	spironolactone and hydrochlorothiazide	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1021	ALDACTAZIDE	spironolactone and hydrochlorothiazide	Pfizer Laboratories Div Pfizer Inc	NDA	Current
59762-5014	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5014	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5014	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5014	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5014	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
66993-188	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-188	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-188	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-188	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84180	SUPPL	2025-11-18
84178	SUPPL	2025-11-17
72972	SUPPL	2022-12-21
72970	SUPPL	2022-12-21
66323	SUPPL	2021-02-23
66316	SUPPL	2021-02-22
64435	SUPPL	2020-08-27
64388	SUPPL	2020-08-24
57249	SUPPL	2019-01-18
57247	SUPPL	2019-01-18
10818	SUPPL	2014-10-24
33089	SUPPL	2014-03-07
12026	SUPPL	2014-03-07
33088	SUPPL	2014-01-22
12025	SUPPL	2014-01-21
10817	SUPPL	2013-06-18
12024	SUPPL	2013-06-13
12023	SUPPL	2011-09-26
12022	SUPPL	2011-05-24
10816	SUPPL	2011-05-23